New Indication Proves Superior Safety of SpaTouch® LHE Technology Study Shows Nearly 90% Clearance of Acne Lesions
ORANGEBURG, N.Y./PRNewswire: Radiancy, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted clearance to its flagship SpaTouch® PhotoEpilation System for patient self use in the removal of unwanted hair. The new Physician Directed Use (PDU) indication confirms the superior safety, ease of use and clinical efficacy of the innovative Light & Heat Energy (LHE™) technology exclusive to the SpaTouch hair removal system.
"The FDA's clearance is a significant corporate milestone, and we are very excited that the SpaTouch PhotoEpiliation System is the first and only one of its type to be classified as a PDU," said Radiancy President Zion Azar,PhD., who invented the proprietary LHE technology. "Our successful clinical results positively establish that SpaTouch is safe and effective for hair removal performed by patients on their own."
In a study designed to evaluate the safety and efficacy of SpaTouch hair removal when used by patients for self treatment in a home-like environment, 67 patients with various skin types (I-IV) and blonde to black hair performed two treatments on two body areas. The first self-treatment was administered at a clinical investigator's office after instruction and guidance by the physician. The second self-treatment was performed 4 weeks later at a hotel room, simulating an at-home environment. Safety and treatment response were evaluated 6 and 12 weeks following the first self-treatment.
Results showed that side effects such as redness and swelling at the treatment site were mild, transient and comparable to previous investigations where a similar device was operated by a healthcare professional. "The basic concept of the study was to determine if the average person could treat him or herself without causing harm. Our work showed that patients may administer self-treatments for hair removal in a safe and effective manner," said Thomas E. Rohrer, MD, the study's lead investigator in Boston.
There are several aspects of the SpaTouch system that contribute to its enhanced safety and ease of use, making it ideal for patients to use at home. The device's unique LHE platform utilizes the heat generated from the light source, enabling the use of low light energy fluences that help avoid the risks associated with high energy lasers. Unlike conventional laser/light- based machines, LHE technology makes optimal use of specific light energy combined with simultaneous heat from the SpaTouch system to produce successful long-term hair removal without significant complications.
The SpaTouch also has a specially designed feature on the hand piece to prevent uncontrolled pulses. Michelle F., a 27-year old restaurant manager, chose her upper thighs and arms for self-treatment of unwanted hair. She characterized the SpaTouch procedure as simple and extremely safe. "On a scale of 1 to 10, I would give SpaTouch a 9 for safety and 7 for ease of use," she said. "Overall I was very satisfied with the procedure and would do it again."
High-tech hair removal is a multi-billion dollar business, and industry experts expect that the number of installed light-based devices will more than double in the next few years. Seven years after the first laser hair removal unit was approved by the FDA, consumers are spending more than $1 billion annually for treatment, making high-tech hair removal one of the fastest- growing cosmetic procedures. According to Dr. Azar, Radiancy remains "110% committed to our customers and to supporting the growth of their hair removal business. This new indication simply confirms the safety profile of SpaTouch technology," he added.
Established in 1998, Radiancy is devoted to the development of unique therapeutic and aesthetic products employing its proprietary LHE platform technology. The global market leader in light-based hair removal devices, Radiancy's Research and Development is based in the Yavne Industrial Park in Israel with its corporate headquarters located in Orangeburg, New York and offices in Asia and Latin America.